NCT04118023

7T MRI to Evaluate Cartilage Defects in the Knee

Improving Non-Invasive Diagnosis and Grading of Cartilage Defects in the Knee - Accuracy of Ultra High Field 7-Tesla MRI as Compared With Arthroscopy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 112 (actual)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose to prospectively evaluate the accuracy of a novel 7-Tesla (7T) knee MRI protocol for the detection and grading of cartilage lesions in the knee, which is a significant limitation of current MRI techniques.

Detailed description

The investigators hypothesize that 7T MRI will be \~ 80% sensitive for detection of cartilaginous lesions. This will be tested in a prospective multi-reader study of 100 patients who are scheduled to have knee arthroscopy. Patients will have two MRIs of the knee: one standard of care and one experimental 7T MRI. Subjects will visit at one time point prior to scheduled knee arthroscopy, for a session time of \~1-2 hours for a single 7T MRI scan.

Conditions

• Cartilage Injury
• Knee Injuries
• Arthropathy of Knee
• Cartilage Damage
• Knee Pain Swelling

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	7 Tesla Magnetic Resonance Imaging Test	MAGNETOM Terra - 7T MRI Scanner by Siemens Healthineers. Each patient enrolled will undergo the study imaging test prior to planned diagnostic knee arthroscopy.

Timeline

• Start date: 2019-10-07
• Primary completion: 2021-08-19
• Completion: 2022-09-07
• First posted: 2019-10-07
• Last updated: 2025-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study